CARD System for Vaccination Pain

Overseen By Victoria Gudzak, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the CARD System for Vaccination Pain treatment?

Research shows that the CARD system, which stands for Comfort, Ask, Relax, and Distract, helps reduce pain and fear during vaccinations, especially in children. It has been shown to improve the vaccination experience by addressing stress-related responses and increasing satisfaction. ^{1 2 3 4 5}

Is the CARD system safe for use in humans?

The CARD system, which stands for Comfort, Ask, Relax, Distract, is a framework used to make vaccinations less stressful and painful. It has been shown to be safe and effective in reducing fear and stress-related responses in children and adults during vaccinations in various settings, including schools and community pharmacies. ^{1 3 6 7 8}

How does the CARD system for vaccination pain differ from other treatments?

The CARD system is unique because it focuses on reducing pain and fear during vaccinations by using a combination of comfort, asking questions, relaxation, and distraction techniques, rather than relying on medication or physical interventions. ^{1 3 6 7 8}

What is the purpose of this trial?

This study is phase 2 of a cluster trial integrating the CARD (Comfort Ask Relax System) in community pharmacies affiliated with Wholehealth Pharmacy Partners. It involves continuing CARD in pharmacies randomized to CARD in phase 1 of the trial (2023-2024 fall/winter vaccination season), and initiating CARD in pharmacies randomized to Control (usual care) in phase 1 of the trial. Both groups will use CARD for delivery of vaccinations during the 2024-2025 fall/winter vaccination season.

Research Team

Anna Taddio, PhD

Principal Investigator

Leslie Dan Faculty Of Pharmacy, University Of Toronto

Eligibility Criteria

This trial is for individuals receiving vaccinations at community pharmacies partnered with Wholehealth Pharmacy Partners. It's specifically designed to assess the CARD system, which aims to reduce vaccination pain and anxiety.

Inclusion Criteria

Clients undergoing vaccination in participating pharmacies

Providers working in participating pharmacies

Exclusion Criteria

Unable to speak and write in English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Pharmacies implement the CARD system for vaccination delivery during the 2024-2025 fall/winter season

6 months

Ongoing visits as needed for vaccinations

Data Collection

Feedback collected from vaccine clients using a paper survey tracking experiences and symptoms during vaccination

6 months

Follow-up

Participants are monitored for implementation outcomes and feedback is collected from providers

3 months

Treatment Details

Interventions

• CARD (Comfort Ask Relax System)

Trial Overview The study tests the 'Comfort Ask Relax Distract' (CARD) system during vaccine administration in two groups: those who used CARD previously and those new to it, comparing its effectiveness in reducing discomfort.

Participant Groups

Group I: Sustained CARD Experimental Treatment 1 Intervention

CARD is being used for the 2nd year in a row as the vaccination delivery framework in participating pharmacies (It was used in the 2023-2024 fall/winter vaccination season and is now being sustained in the 2024-2025 fall/winter season). CARD comprises of education, environment, engagement and evaluation components.

Group II: First-time CARD Active Control 1 Intervention

CARD is being used for the 1st time as the vaccination delivery framework in participating pharmacies (2024-2025 fall/winter vaccinations only). CARD comprises of education, environment, engagement and evaluation components.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Wholehealth Pharmacy Partners

Collaborator

Trials

2

Recruited

2,500+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Managing pain and fear: Playing your CARDs to improve the vaccination experience. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Procedural and Physical Interventions for Vaccine Injections: Systematic Review of Randomized Controlled Trials and Quasi-Randomized Controlled Trials. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

CARD (Comfort Ask Relax Distract) for community pharmacy vaccinations in children: Effect on immunization stress-related responses and satisfaction. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review of measures for reducing injection pain during adult immunization. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Thermomechanical Stimulation during Vaccination on Anxiety, Pain, and Satisfaction in Pediatric Patients: A Randomized Controlled Trial. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of the CARD (Comfort Ask Relax Distract) system on school-based vaccinations: A cluster randomized trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

COVID-19 Vaccination Delivery in Long-Term-Care using the CARD (Comfort Ask Relax Distract) System: Mixed Methods study of Implementation Drivers. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Integration of CARD (Comfort Ask Relax Distract) for COVID-19 community pharmacy vaccination in children: Effect on implementation outcomes. [2023]